Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP production, leading to pharmacokinetics/pharmacodynamic clinical trials. Chicago-headquartered Novel351k, meanwhile, will contribute its experience with regulatory and clinical strategies to accelerate the development of the programs toward commercialization.
Pending a successful outcome of early-stage trials, the companies anticipate the partnership will progress to late-stage development activities and commercial manufacturing.
The therapeutics developed under the partnership have a current annual market value exceeding $15bn.
The co-development agreement has a projected value of $100m over more than ten years, including development milestones and royalties.
Launched in May last year as the biosimilars unit of JSR Life Sciences, the Similis Bio business operates a partnering program to help biopharmaceutical companies improve the efficiency and cost of biosimilar development, ‘relying on core expertise in developing and manufacturing biologics to mitigate the challenges inherent in biosimilar drug development’.
In October, it announced its first agreement with Brazil’s Blau Farmaceutica to co-develop four biosimilar programs across a broad range of indications: with the total value of the contract expected to exceed $100m.
